Parental Permission and Child Assent

Research involving children must respect both the responsibilities of parents or legally authorized representatives and the child’s developing autonomy, understanding, preferences, and right to participate in decisions about research.

Where a child is not legally or ethically capable of providing independent informed consent, permission must be obtained from the parent, legal guardian, or other legally authorized representative as required by applicable law and the approved research protocol. When the child is capable of understanding the proposed research and expressing a meaningful preference, the child’s assent should also be sought.

The 2024 Declaration of Helsinki requires consent from a legally authorized representative for participants incapable of giving free and informed consent and additionally requires assent when such participants are capable of expressing it. Their expressed preferences and values should be considered, and their dissent should be respected.

Parental or Legally Authorized Representative Permission

Permission must be obtained from the person or persons legally authorized to make decisions on behalf of the child in accordance with applicable law, institutional requirements, and the determination of the responsible ethics committee.

The journal does not prescribe a universal requirement that one or both parents must provide permission. The applicable requirement depends on the jurisdiction, nature and risk of the research, ethics committee approval, and the child’s legal circumstances.

The permission process should provide sufficient understandable information about:

• the purpose and nature of the research;
• research procedures and their duration;
• foreseeable risks, discomforts, and burdens;
• expected benefits, if any;
• available alternatives where relevant;
• confidentiality and use of personal information or biological materials;
• compensation or reimbursement, where applicable;
• whom to contact about the research or participants’ rights;
• the voluntary nature of participation and the right to withdraw.

Permission must be given voluntarily and without coercion, inappropriate pressure, or misleading information.

Child Assent

Assent is the child’s affirmative agreement to participate in research when the child is not legally able to provide full independent informed consent but has sufficient capacity to understand the research at an appropriate level.

Assent is more than the absence of objection. Researchers should actively explain the research to the child and seek an affirmative expression of willingness to participate whenever the child is capable of providing it.

The ability to provide assent should be evaluated according to the individual child’s:

• age;
• developmental and cognitive capacity;
• maturity;
• health and emotional condition;
• ability to understand the research;
• ability to communicate a preference.

The journal does not impose a single fixed age at which assent must begin. Requirements should follow applicable law, ethics committee decisions, and the individual child’s capacity.

Age- and Development-Appropriate Information

Information should be communicated in a language, format, and level of complexity appropriate to the child’s age and developmental capacity.

Where appropriate, children should be informed about:

• why the research is being conducted;
• what will happen to them;
• which procedures are part of research rather than routine clinical care;
• whether procedures may cause discomfort or inconvenience;
• whether there may be benefits;
• how their information will be protected;
• whom they may ask questions;
• their ability to say that they do not want to participate or wish to stop.

Researchers should verify the child’s understanding rather than relying solely on the provision of a written information sheet.

Respect for Dissent

A child’s clear objection or dissent should be taken seriously and should ordinarily be respected, particularly when the child is capable of understanding the relevant aspects of the research.

A parent’s or legal representative’s permission should not automatically override a capable child’s expressed unwillingness to participate.

The 2024 Declaration of Helsinki specifically states that when a person incapable of providing full informed consent can nevertheless provide assent, that assent must be sought in addition to representative permission and the participant’s dissent should be respected.

Any exceptional circumstances in which dissent cannot be handled in the usual way must have a clear ethical and legal basis and must be addressed in the research protocol and by the responsible ethics committee.

Voluntariness and Protection from Pressure

Children may be particularly susceptible to influence from parents, clinicians, teachers, caregivers, researchers, or other authority figures.

Researchers must therefore ensure that neither parental permission nor child assent results from coercion, intimidation, excessive inducement, or inappropriate influence.

The child should not be made to believe that refusing research participation will result in punishment, disappointment of caregivers or clinicians, loss of routine medical care, or other inappropriate consequences.

Where the treating clinician is also a researcher or another dependent relationship exists, appropriate measures should be used to minimize undue influence.

Changing Capacity and Re-Consent

A child’s capacity to participate in decision-making may change during a longitudinal or long-term study.

Researchers should reassess assent where appropriate as the child develops or when circumstances materially change.

If a participant reaches the legally recognized age or capacity for independent informed consent while still actively participating in research, their own informed consent should be obtained for continued participation when required by applicable law, ethics committee approval, or the nature of the study.

Previously obtained parental permission should not automatically substitute indefinitely for the participant’s own consent after independent consent becomes applicable.

Waiver or Modification

Parental permission or assent may be waived or modified only where this is ethically justified, legally permitted, and appropriately approved by the responsible ethics committee or other competent body.

Researchers must not independently decide to omit required parental permission or child assent for reasons of convenience, recruitment difficulty, or study efficiency.

Where a waiver or modification has been approved, the manuscript should describe this accurately and identify the responsible ethics body where applicable.

Emergency and Incapacity Situations

Research conducted in emergency circumstances or involving children for whom permission cannot immediately be obtained requires particular safeguards.

Research without prior permission may proceed only where the applicable ethical and legal requirements permit it and where the relevant conditions have been prospectively addressed and approved by an ethics committee.

The 2024 Declaration of Helsinki permits research involving persons unable to consent in specific circumstances only under strict conditions, including ethics committee approval; appropriate consent must subsequently be obtained as soon as possible where required.

Research Consent and Consent for Publication

Permission for a child to participate in research is not the same as consent for publication of identifiable information.

If a manuscript contains potentially identifiable clinical photographs, case details, pedigrees, genetic information, or other identifying material, separate publication-consent requirements may apply.

ICMJE states that identifiable patient information should not be published unless scientifically necessary and written informed consent for publication has been obtained from the patient or, where applicable, the parent or guardian.

Detailed requirements are provided in the journal’s Consent for Publication section.

Reporting in the Manuscript

For pediatric research, authors should state, as applicable:

• whether parental, guardian, or legally authorized representative permission was obtained;
• whether child assent was obtained;
• the basis for determining whether assent was appropriate;
• whether a waiver or modification was approved;
• the responsible ethics committee and relevant approval information.

Authors should not claim that consent or assent was obtained unless the procedures actually followed support that statement.

Journal Verification

The journal may request relevant documentation, including participant information sheets, parental permission forms, assent materials, ethics committee decisions, waiver documentation, or clarification of the consent procedure.

The journal may also assess whether the information and consent arrangements were reasonably appropriate for the age, developmental capacity, vulnerability, and clinical circumstances of the participants.

Failure to obtain required parental permission or child assent, fabrication of consent documentation, or material misrepresentation of the consent process may result in rejection or action under the journal’s Research Misconduct, Editorial Actions, and Corrections and Retractions policies.